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Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.
- Source :
-
Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz [Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz] 2010 Jan; Vol. 53 (1), pp. 24-9. - Publication Year :
- 2010
-
Abstract
- The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed.
- Subjects :
- Europe
Gene Transfer Techniques
Guidelines as Topic
Humans
Quality Assurance, Health Care legislation & jurisprudence
Cell Transplantation legislation & jurisprudence
Clinical Trials as Topic legislation & jurisprudence
Genetic Therapy legislation & jurisprudence
Marketing of Health Services legislation & jurisprudence
Tissue Engineering legislation & jurisprudence
Subjects
Details
- Language :
- English
- ISSN :
- 1437-1588
- Volume :
- 53
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
- Publication Type :
- Academic Journal
- Accession number :
- 19940964
- Full Text :
- https://doi.org/10.1007/s00103-009-0991-5